CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 32 enrolled
Drug / intervention
raltegravir +3 moredrug
Likely dose
emtricitabine 200mg /tenofovir 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01154673
NCT01154673Phase 3Completed
CompareCT.gov

Randomized, Double-blinded, Controlled Trial of Intensive HAART Including Raltegravir, and Maraviroc, on HIV-1 Pro-viral DNA and Reservoir Decay in HIV-1-infected Individuals During the Acute/Early Infection

University of Toronto·interventional·Posted Jul 1, 2010·Updated Apr 5, 2016

In Brief

A Phase 3 clinical trial evaluating raltegravir, maraviroc, and 2 other interventions for Acute HIV Infection. Completed, enrolled 32 participants across 2 sites.

Detailed Summary

This trial will investigate the efficacy and safety of intensified antiretroviral treatment that includes raltegravir and maraviroc during the early stages of HIV infection. With the proven efficacy of these antiviral drugs in pre- and post-clinical trials, we would like to investigate the ability of the combination of raltegravir and maraviroc plus a standard HAART backbone to further decrease the viral load in acutely infected treated HIV infected individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute HIV Infection
CountriesCanada
CollaboratorsUnity Health Toronto, Maple Leaf Research

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 1, 2010
Enrollment StartNov 1, 2011
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.0 years ago

Interventions

raltegravirdrug

Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART

maravirocdrug

Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART

emtricitabine 200mg /tenofovir 300mgdrug

emtricitabine 200mg /tenofovir 300mg QD

lopinavir 400 mg/ritonavir 100mgdrug

lopinavir 400 mg/ritonavir 100mg BID